Kornimate/medical-research-clean huggingface dataset:
effect of intermittent pneumatic compression on ulcer healing in subjects with secondary lymphedema

Conditions: Lymphedema

Summary: this is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (ipc)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the ipc-treated group (ipc plus standard compression)and control (standard compression alone).


Eligibility criteria:
inclusion criteria: * diagnosed with secondary lymphedema * presence of a venous ulcer that has not healed in more than 6 months * localized wound pain greater than 3 with vas * ulcer must be on lower leg (below knee) * ulcer must be of venous etiology * cvi proven by duplex studies * subject must have adequate arterial blood flow (abi \> 0.70) * subject must be able to tolerate compression bandages * subject must be ambulatory * capable of understanding consent process exclusion criteria: * wound infection * ulcer of non-venous etiology * ulcer on toes or plantar surface of the foot * subject taking any medication that in the opinion of the investigator affects wound healing * alcohol or drug abuse * active deep venous thrombosis (dvt) * subject has a cancer diagnosis * diabetic with hemoglobin a1c\>12 * arterial insufficiency abi\<0.70 * subject is not capable of walking (wheelchair-bound or bed-bound) * subject currently enrolled in another clinical trial * moderate to severe congestive heart failure

Keywords: venous ulcer secondary lymphedema chronic lower leg ulceration
influence of glycaemic balance on the ability of apolipoprotein c1 to inhibit cholesteryl ester transfer protein in type-1 diabetes patients

Conditions: diabète de Type 1

Summary: in type-1 diabetes patients, bad cholesterol tends to accumulate because apoc1 function is slowed down. apoc1 is a protein whose role is to diminish the activity of cetp, another protein that regulates cholesterol transfer in the body. the aim of this study is to determine whether it is possible to correct apoc1 function by improving glycaemic balance. 240 persons will be recruited in this study and allocated to one of two groups: * 160 type-1 diabetes patients with uncontrolled diabetes: * 4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later. * 80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays. * 4 blood samples will be taken at the time of inclusion.


Eligibility criteria:
inclusion criteria for patients: * patients over 18 years * patients with type-1 diabetes and glycated hemoglobin (hba1c) \>9% inclusion criteria controls: * subjects over 18 years * normal glycaemia (fasting glycaemia \<1.10 g/l) and normal lipids (low-density lipoproteins (ldl) \<1.6 g/l, triglycerides (tg) \<1.5 g/l) exclusion criteria: exclusion criteria patients: * adults under guardianship * patients without national health insurance * pregnant or breast-feeding women * progressive cancer * treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy) exclusion criteria controls: * adults under guardianship * persons without national health insurance * pregnant or breast-feeding women * known dyslipidemia and/or lipid-lowering treatment * treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
internet delivered cbt for ocd in adolescents with asd - a clinical case series

Conditions: Obsessive Compulsive Disorder; Autism Spectrum Disorder

Summary: the aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (icbt) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (ocd) in adolescents with ocd and autism spectrum disorder (asd). this feasibility study will inform us how to adapt the original intervention to the specific needs of patients with asd.

to evaluate the effectiveness of icbt for ocd in adolescents with asd, this study will use a single case experimental design with weekly measures during two phases: a-b. the a-phase will consist of baseline measures at least three weeks prior to treatment. the b-phase will consist of the 12 weeks icbt-program as well as one measure post-treatment. single case descriptions of each participant will be presented. weekly measures on the obsessional compulsive inventory - child version (oci-cv) will be analyzed through visual inspection of each participants graph and through computation of percentage of non-overlapping data (pnd). pnd is a frequently used effect measure in sced and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase. to assess the feasibility and comprehension of the icbt treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of icbt and semi-weekly during the rest of the treatment. detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the icbt protocol to better suit patients with asd.

Eligibility criteria:
inclusion criteria: * a diagnosis of ocd as defined by dsm-5 \[40\] * a diagnosis of autism defined by dsm-5 * a total score of ≥ 16 on the children's yale-brown obsessive-compulsive scale, cy-bocs \[14\] * age between 12 and 17 years * ability to read and write swedish * access to the internet * a parent that is able to co-participate in the treatment * participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment exclusion criteria: * psychosis or bipolar disorder, severe eating disorder * suicidal ideation * subject not able to read or understand the basics of the icbt material * completed cbt for ocd within last 12 months (defined as at least 5 sessions of cbt including exposure and response prevention) * ongoing psychological treatment for ocd or another anxiety disorder
uva light device to treat covid-19

Conditions: Coronavirus

Summary: this pilot study will assess the safety and effectiveness of uv light treatment in hospitalized patients with covid-19.

this is a single center, open label, pilot study. 5 adult patients, aged over 18, who are confirmed positive with sars-cov-2 and are newly intubed, will receive uv light treatment to reduce sars-cov-2 viral load.

Eligibility criteria:
inclusion criteria: * confirmed positive test result for sars-cov-2 * mechanically ventilated * endotracheal tube inner diameter of at least 7.5 mm exclusion criteria: * unable to provide informed consent (or surrogate) * enrolled in a therapeutic clinical trial for same condition that does not allow recruitment in other trials * pregnant women
follow-up of post-spinal implantable neurostimulator precision®

Conditions: Chronic Refractory Neuropathic Pain; Ischemic Peripheral Pain

Summary: assessing the long-term efficacy, complications, revision rates and final explantation of the device

longitudinal study with a follow-up of 2 years in patients implanted with the precision neurostimulator. this study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device

Eligibility criteria:
inclusion criteria: * adult patient receiving spinal implantation of a neurostimulator precision ® ( primary implantation or reimplantation) exclusion criteria: * refusal of patient * patient whose long-term monitoring will not be possible

Keywords: medullary neurostimulation pain precision rechargeable implantable
text-based support for parents of adolescents following an emergency department visits

Conditions: Suicide

Summary: the goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

participants will be 420 adolescents (ages 13-17) seen in ed with recent suicidal ideation and/or attempt and their parents recruited from two health system eds in the midwest.

Eligibility criteria:
inclusion criteria: * adolescent (13-17 years old) who present to emergency department (ed) due to (1) last-week suicidal ideation and/or (2) last-month suicide attempt, and their caregiver. exclusion criteria: adolescents who are: * medically unstable * presenting with severe cognitive impairment, altered mental status, severe aggression/agitation * presenting without a legal guardian * whose parent does not own a cell phone

Keywords: text suicidal ideation suicide attempt
high-activity natural killer immunotherapy for small metastases of colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of colorectal cancer.

by enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: metastatic colorectal cancer high-activity natural killer
transversus abdominis plane versus quadratus lumborum block for pediatrics

Conditions: Postoperative Pain

Summary: the purpose of this research study is to find the best way to decrease pain in children whom have had low abdominal surgery. investigators will perform two technique of trunk block; transversus abdominis plane or quadratus lumborum block .the method used is often chosen by which one the doctor has more experience using. the investigator plans to find out if one of the methods is more effective and/or safer than the other method. the results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study. children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure. after preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).after ethical committee approval, informed written consent will be obtained from all patients. consenting patients scheduled to have unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral quadratus lumborum block or transversus abdominis plane block at the begin of surgery. all patients will be in the lateral position . under ultrasound guidance a 22 gauge, pajunk sonoplex(medical germany) needle will be used for both techniques. the spread of injectate will be seed on ultrasound.the dose of local anaesthetic in both groups will be 0.5 ml/kg 0.2 % bupivacaine. anesthesia would be maintained with 2% sevoflurane an increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. saline dextrose 5% (1:1) solution was infused in a dose of 12 ml/ kg /h. all patients heart rate,map and oxygen saturation record intraoperatively. all patients will receive paracetamol if requirement for postoperative analgesia.all patient will transfer from pacu to day-surgery unit (dsu) if they achieved modified aldrete score of ten. all patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.flacc score will be used.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii * undergoing unilateral low abdominal surgery exclusion criteria: * history of allergic reactions to local anesthetics * rash or infection at the injection site * anatomical abnormality * bleeding diatheses, coagulopathy, liver diseases
aging brain care virtual program

Conditions: Dementia; Alzheimer Disease

Summary: the program involves a virtual intervention to be delivered by rn or sw care coordinators over one year. every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. the intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.


Eligibility criteria:
patient inclusion criteria: * 65 and older, * active primary care patient (visit in past 14 months), * diagnosis of alzheimer's disease and related dementias (adrd) based on icd criteria in primary care problems list. patient exclusion criteria: * enrolled in hospice at the study start (study screening)or * living in a long term care nursing facility. care partners inclusion criteria: * 18 and older, * able to access a phone or computer for intervention delivery in english, and * identified in the emr as the emergency contact or as the primary care partner. care partners exclusion criteria: - individuals who decline to participate in the abcv intervention

Keywords: telehealth virtual intervention aging brain care
is xylitol toothpaste effective in preventing tooth decay?

Conditions: Dental Caries

Summary: the study will identify children at high caries risk and then advise/instruct their parents/caregivers in practicing evidence-based risk-based at home preventive measures for their infants with daily use of xylitol or fluoride toothpaste. this study plan to invite the children aged 12-15 months old with high caries risk to do the clinical trial. every infants will be randomly allocated into two groups. participants in the test group will be asked to use xylitol (20%) toothpaste to brush their teeth twice every day with the help of caregivers. participants in the test control group will be asked to use fluoride (1000ppm) toothpaste to brush their teeth twice every day with the help of caregivers. the same oral health instruction and children' diet instruction will be done for every participant's caregivers. for every dental examination, clinical chatting form for the children will be collected after filling in by examiner. questionnaire will be collected after filling in by the caregivers. and infants' plaque and saliva will be collected to detect the s. mutans level. we plan to do the dental examination three times for one infant including the first time recruiting, one year follow-up, and two year follow-up. the establishments of the good oral health-related habits will safeguard and have sustained benefits for the children. the study can provide evidence on the effectiveness of xylitol toothpaste and risk of high fluoride toothpaste among young children. in the long term, the findings of the study might serve as a foundation for establishing an effective oral health care promotion programme throughout hong kong and beyond. the framework, if shown to be effective, could help development of the oral health policies and promotion programmes to achieve better oral health among young children eventually.


Eligibility criteria:
inclusion criteria: infants aged 12-15 months old with high caries risk exclusion criteria: infants who has systematical disease
remote assessment of lung disease and impact on physical and mental health

Conditions: Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Covid19

Summary: this cohort study aims to use the open-source radar-base mhealth platform to collect and analyze datasets associated with lung disease. this will include continuous data collected from wearable devices (e.g. heart rate, oxygen saturation, respiratory rate), including pulse oximeters, spirometer, mobile phones, digital tests, and smart phone symptom questionnaires.


Eligibility criteria:
inclusion criteria: * 20 patients with a diagnosis of copd * 20 patients with a diagnosis of interstitial lung disease * 20 a clinical diagnosis of covid-19 (within 4-13 weeks of enrolment) who either and report symptoms interfering with day to day activity present for more than 28 days following the onset of covid-19 * prior mobile phone use * willingness to use monitoring devices and complete study questionnaires. * history of exacerbation (copd: 2 or more exacerbations in last 1 yr) exclusion criteria: * non english language speaker * lack of physical capability to take part e.g. heart failure * pregnancy * lack of capability to consent
association of pulsatility and occurrence of complications related to mechanically assisted circulatory support

Conditions: End-stage Heart Failure

Summary: the primary objective of this study is to determine whether preserved pulsatility for patients supported by cf-lvad (continuous flow left ventricular assist device) is associated with less acquired deficiency of the von willebrand factor, a blood glycoprotein involved in hemostasis.

implantation of lvads (left ventricular assist device) is a medium to long-term therapeutic option for patients with end-stage heart failure and isolated left ventricular dysfunction. nevertheless, lvads use remain limited by the frequency of their adverse effects, most of which being unpredictable. in the literature, loss of pulsatility seems to be associated with cf-lvads complications, including bleeding. accordingly, the primary objective of this study is to determine whether patient's preserved pulsatility is associated with less acquired deficiency of the von willebrand factor (vwf), a blood glycoprotein involved in hemostasis. this deficiency, characterized by a decrease or absence of vwf high molecular weight multimers (hmwms), is present to varying degrees in almost all patients with lvads and is a major risk factor for bleeding complications in these patients. pulsatility is estimated by the patient's blood pressure differential, measured 1) at discharge from the operating room (=transfer to care), 2) at discharge from care (=transfer to his or her room), 3) at discharge from the hospital (=transfer to rehabilitation), and then at each follow-up visit up to 6 months post-implantation. the primary endpoint is to determine whether a preserved pulsatility is associated with less acquired deficiency of the von willebrand factor ratio of high molecular weight multimers (hmwms).

Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age 2. patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the rcp of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy). 3. patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding ame) 4. signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so exclusion criteria: 1. heart transplant patients 2. patients who already had lvad 3. chronic renal failure patients on dialysis 4. patients refusing to give informed consent 5. patients deprived of liberty or under legal protection (guardianship, curators) 6. pregnant or breastfeeding women 7. ongoing participation in another intervention research protocol except levoecmo project (nct04728932) and anchor project (nct04184635)

Keywords: lvad pulsatility index von willebrand factor
randomised study to compare the effect of r-hu-epo administration with transfusion of red blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course

Conditions: - Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)

Summary: randomised study to compare the effect of r-hu-epo administration with transfusion of red blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.


Eligibility criteria:
inclusion criteria: * both sexes * 18-70 yrs * metastatic or locally advanced cancer * life expectancy \> 3 months * hemoglobin between 7 and 10 g/100ml * no contraindication to r-hu-epo * with written informed consent at entry time
ultrasound-assisted or landmark-based intrathecal administration of nusinersen in adult patients with spinal muscular atrophy (the echospin study)

Conditions: Anesthesia, Spinal; Spinal Puncture Complications; Spinal Muscular Atrophy; Ultrasonography

Summary: nusinersen (spinraza, biogen inc, boston, ma), the first treatment approved by fda and ema for all spinal muscular atrophy (sma) subtypes, is an antisense oligonucleotide that is administered intrathecally through a lumbar puncture. this procedure can be challenging in some adults with intermediate and late onset sma (types ii-iv) frequently presenting scoliosis secondary to neuromuscular weakness and often treated with spinal instrumentation to prevent worsening deformities. in such patients, in order to access the intrathecal space, us guidance and/or assistance have been recently proposed as useful and successful tool. the us guidance and/or assistance have been associated to a high success rate, a reduction of number of attempts and needle passes to obtain a successful anesthesia. a reduced risk of adverse events (aes), such as post dural puncture headache (pdph) and low back pain (lbp), and low patient satisfaction often associated with multiple needle punctures was also reported. aim of this retrospective study was to report the efficacy, evaluated as rate of the successful procedures and subsequent delivery of nusinersen within the subarachnoid space, the number of attempts, the procedure time and the adverse events (aes) of interlaminar intrathecal nusinersen administration using either ultrasound assistance or the landmark-based technique in a historical cohort of 51 adult sma patients.


Eligibility criteria:
inclusion criteria: * a genetically confirmed diagnosis of sma * treatment with nusinersen exclusion criteria: * congenital coagulopathy, * localized infections, * increased intracranial pressure.